Events

Recall of Hallu-Fix Drill, Diameter 1.9mm, supplied in Hallu-Fix system instrumentation set (used for orthopaedic foot surgery)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Integra Neurosciences Pty Ltd.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    RC-2016-RN-01387-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-10-20
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01387-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • Extra notes in the data
  • Reason
    The manufacturer has identified a defect in lot fe58 of hallu-fix drill diameter 1.9mm, where the drill may not be sharp enough to prepare screw holes. the defect can be easily recognised during use and an increase of surgery time may be observed while another similar drill is found to prepare the screw holes. if an affected drill is used, the defect can contribute to an increase of surgery time of approximately 10 minutes and require a higher pressure on the drill. this pressure may cause minimal transient tissue damage and difficulties to achieve the surgery. to date no injury or adverse event has been reported.
  • Action
    Integra Neurosciences is advising customers to review their inventory for the affected drill and stop using the affected drill immediately. Integra will provide directions for return of the product and will replace affected stock. This action has been closed-out on 18/05/2017.

Device

Hallu-Fix Drill, Diameter 1.9mm, supplied in Hallu-Fix system instrumentation set (used for ortho...
  • Model / Serial
    Hallu-Fix Drill, Diameter 1.9mm, supplied in Hallu-Fix system instrumentation set (used for orthopaedic foot surgery)Catalogue Number for Drill: 119618ND Lot Number: FE58 ARTG Number: 174104
  • Manufacturer
    Integra Neurosciences Pty Ltd

Manufacturer

Integra Neurosciences Pty Ltd